Reagents and supplies for PacBio Revio HiFi sequencing platform

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology, in order to determine if there are existing small business sources capable of providing the items described herein. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov.

Background:  

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology requires the purchase of reagents and supplies to support error-corrected next generation sequencing on an existing PacBio Revio HiFi sequencing platform to identify tobacco-derived nicotine (TDN) mutations—a primary aim of a 28-day subacute TDN inhalation genotoxicity study. The items listed below will generate sequencing data for NCTR Center for Tobacco Products (CTP) project E07877.01. The PacBio platform is ideal for identifying ultra-low-frequency somatic mutations because its HiFi sequencing generates virtually error-free consensus reads through built-in error correction.

This requirement is configured as Brand Name or Equal:

• 102-202-200 Revio SMRT Cell tray
• 103-504-900 Revio SPRQ sequencing plate
• 100-667-601 Sequencer pipet tips
• 102-009-200 Revio SMRT Bell Adapter index plate 96A
• 102-182-700 Revio SMRT Bell Prep kit 3.0

Salient Characteristics (that an “or equal” product shall meet):

1. Sequencing kits and reagents shall be compatible with existing PacBio Revio, Serial Number: 84183
2. 102-202-200 Revio SMRT Cell tray
   1. Shall fit inside the Revio instrument.
   2. Shall contain 4 SMRT cells for sequencing on the Revio system.
3. 103-504-900 Revio SPRQ sequencing plate
   1. Shall contain reagents for sequencing 4 Revio SMRT Cells
4. 100-667-601 Sequencer pipet tips
   1. Shall include 40 boxes of robotic liquid handling pipet tips (96 tips per box, for a total of 3,840 tips).
5. 102-009-200 Revio SMRT Bell Adapter index plate 96A
   1. Shall include 96 indexed SMRTbell adapters in plate format (1 sample per index).
   2. Shall include indexes bc2001-bc2096.
6. 102-182-700 Revio SMRT Bell Prep kit 3.0
   1. Shall include all reagents for library preparation with SMRTbell adapter (24 samples)
   2. Shall include SMRTbell cleanup beads and low TE buffer.
      1. SMRTbell cleanup beads shall be equivalent to the PacBio item # 102-158-300, which contain 10 ml paramagnetic beads for the rapid purification of double stranded DNA.
      2. The 10 ml Low TE buffer included in prep kit shall contain 10mM Tris-HCl (pH 8.0) and 0.1mM EDTA solution and shall be equivalent to the PacBio item # 102-178-400.
7. One SMRT cell shall be utilized in each sequencing reaction, and experiments shall be able to be run on a single cell or in batch mode.

Warranty:

Reagents shall be warranted for not less than 6 months from FDA acceptance.

Delivery Terms:

FOB Point: Destination. All items shall include shipping, handling and inside delivery. Quoter shall use appropriate shipping methods to ensure viable reagents upon delivery.

Delivery shall occur within 90 calendar days from date of award.

Delivery Location:

FDA - NCTR

3900 NCTR Rd

Jefferson, Arkansas 72079

Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service.  Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, unique entity identification (UEI) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered items/services meet the technical requirements identified above.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Informational pricing is desired.

• The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before July 21, 2025, by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-130433.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.